On April 28, 2023 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, reported FDA orphan drug designation for INB-400 and INB-410, covering a broad range of malignant glioma treatments, including newly diagnosed GBM (Press release, In8bio, APR 25, 2023, View Source [SID1234630669]). As an industry leader in gamma-delta T cell development, this milestone marks the first genetically modified gamma-delta T cell therapy to receive this designation, which offers potential incentives such as 7-year market exclusivity.
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In December 2022, the FDA cleared IN8bio’s investigational new drug application (IND) for a Phase 2 clinical trial in newly diagnosed GBM for INB-400. With Institutional Review Board (IRB) review and site initiation ongoing, patient enrollment is expected to begin in the second half of 2023.
"Our goal is to achieve our Mission of Cancer Zero by eradicating cancer cells and improving patient outcomes," said IN8bio CEO and co-founder, William Ho. "Our novel approach combines engineered, chemo-resistant gamma-delta T cells with standard-of-care treatments to amplify immune signals, maximize tumor killing, and eliminate more cancer cells. We eagerly anticipate enrolling our first Phase 2 patients for INB-400 later this year."
GBM, a highly aggressive and difficult-to-treat brain cancer, has remained largely unchanged in treatment options for over 18 years, with a median progression-free survival of 6-7 months and overall survival of 14-16 months.
Orphan drug designation benefits IN8bio through incentives such as potential additional market exclusivity following approval, tax credits on qualified US clinical trials, eligibility for orphan drug grants, and exemption from certain fees. With this milestone, IN8bio continues to progress its pipeline programs and will provide further clinical updates on its pipeline at medical meetings throughout the year.
About INB-400
INB-400 is IN8bio’s DeltEx chemotherapy resistant autologous and allogeneic DRI technology. Allogeneic INB-400 will expand the application of DRI gamma-delta T cells into other solid tumor types through the development of allogeneic or "off-the-shelf" DeltEx DRI technology.